Medication Monitor

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  • August 4, 2015

    Aprecia Pharmaceuticals Co. announced that FDA has approved levetiracetam for oral use as a prescription adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures, and primary generalized tonic–clonic seizures in adults and children with epilepsy. 

    Aprecia's ZipDose Technology platform uses three-dimensional printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid. While 3DP has been used previously to manufacture medical devices, this approval marks the first time a drug product manufactured with this technology has been approved by FDA.

    ZipDose Technology enables the delivery of a high drug load, up to 1,000 mg in a single dose. In addition, no measuring is required, as each dose is individually packaged, making it easy to carry this treatment on the go.

    The product is expected to be available in the first quarter of 2016.

  • November 30, 2018

    FDA is warning about genetic tests with claims to predict how a person will respond to specific medications in cases where the relationship between genetic (DNA) variations and the medication's effects has not been determined. These genetic tests might be offered through health care providers or advertised directly to consumers and claim to provide information on how a patient will respond to medications used to treat conditions such as depression, heart conditions, acid reflux, and others. They might claim to predict which medication should be used or that a specific medication may be less effective or have an increased chance of adverse effects compared with other medications due to genetic variations.

    Results from these tests may also indicate that the health care provider can or should change a patient's medication on the basis of these test results. FDA is also aware of software programs that interpret genetic information from a separate source that claim to provide this same type of information. However, sufficient clinical evidence is not currently available for these genetic tests or software programs, and therefore, these claims are not supported for most medications.

    According to the agency, patients and health care providers should not make changes to a patient's medication regimen on the basis of results from genetic tests that claim to predict a patient's response to specific medications, but are not supported by sufficient scientific or clinical evidence to support this use. Doing so may put the patient at risk for potentially serious health consequences.

    There are a limited number of cases for which at least some evidence does exist to support a correlation between a genetic variant and drug levels within the body, and this is described in the labeling of FDA cleared or approved genetic tests and FDA-approved medications. FDA-authorized labels for these medical products may provide general information on how DNA variations may affect the levels of a medication in a person's body, or they may describe how genetic information can be used to determine therapeutic treatment, depending on the available evidence.

    Recommendations for health care providers and laboratories

    • If you are using, or considering using, a genetic test to predict a patient's response to specific medications, be aware that for most medications, the relationship between DNA variations and the medication's effects has not been established. Check the FDA-approved drug label, or the label of the FDA-cleared or approved genetic test for information regarding whether genetic information should be used for determining therapeutic treatment.
    • If a patient brings you a test report from a genetic test offered directly to consumers that claims to predict a person's response to a specific medication, seek information in the FDA-approved drug label regarding whether genetic information should be used for determining therapeutic treatment.
    • Be aware that there are some FDA-approved drug and genetic test labels, and labels of FDA-cleared genetic tests that provide general information about the impact of DNA variations on drug levels, but do not describe how that genetic information can be used for determining therapeutic treatment. These labels are intended to be informational, but do not indicate that there is sufficient evidence to support making treatment decisions based on the information provided by the genetic test.
    • Know that information regarding therapeutic treatment recommendations for patients with certain genetic variations can be found in the warnings (Boxed Warning, or Warnings and Precautions), Indications and usage, Dosage and Administration, or Use in Specific Populations sections of the FDA approved drug labeling, as appropriate.
    • Be aware that most genetic tests that make claims regarding effects of a specific medication have not been evaluated by FDA.

  • October 26, 2015

    FDA approved trabectedin, a chemotherapy drug, for the treatment of specific soft tissue sarcomas—liposarcoma and leiomyosarcoma—that cannot be removed by surgery or is metastatic. This treatment is approved for patients who previously received chemotherapy that contained anthracycline.

    Effectiveness and safety of trabectedin were demonstrated in 518 clinical trial participants with metastatic or recurrent leiomyosarcoma or liposarcoma. Participants were randomly assigned to receive either trabectedin (345 patients) or dacarbazine (173 patients), another chemotherapy drug.

    Participants who received trabectedin experienced a delay in the growth of their tumor (progression-free survival), which occurred on average about 4.2 months after starting treatment, compared with participants assigned to dacarbazine, whose disease progressed an average of 1.5 months after starting treatment.

    The most common adverse effects among participants were nausea, fatigue, vomiting, diarrhea, constipation, decreased appetite, shortness of breath, headache, tissue swelling, neutropenia, thrombocytopenia, anemia, elevated liver enzymes, and decreases in albumin.  

    Trabectedin carries a warning alerting health care providers of the risk of severe and fatal blood infections, muscle tissue breakdown, liver damage, leakage around the vein or catheter, tissue necrosis, and heart failure. Patients with known hypersensitivity to trabectedin, a drug used to treat cancer, should not take trabectedin.

    Health care providers are also encouraged to advise women of potential risks to a developing fetus when taking trabectedin. Women who are taking the medication should not breastfeed.

  • December 2, 2015

    FDA approved mepolizumab for use with other asthma medicines for the maintenance treatment of asthma in patients aged 12 years and older who have a history of severe asthma attacks despite receiving their current asthma medicines. 

    The agent, a humanized interleukin-5 antagonist monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary cells, treats severe asthma attacks by reducing the levels of blood eosinophils, a type of white blood cell that contributes to the development of asthma.

    The medication is administered by a health professional once every 4 weeks by subcutaneous injection into the upper arm, thigh, or abdomen. 

    Safety and efficacy were established in three double-blind, randomized, placebo‑controlled trials in patients with severe asthma on currently available therapies. Mepolizumab or a placebo was administered to patients every 4 weeks as an add-on asthma treatment.

    Compared with placebo, patients with severe asthma receiving mepolizumab had fewer exacerbations requiring hospitalization and/or emergency department visits and a longer time to the first exacerbation. In addition, patients with severe asthma receiving mepolizumab experienced greater reductions in their daily maintenance oral corticosteroid dose while maintaining asthma control, compared with patients receiving placebo.

    Treatment with mepolizumab did not result in a significant improvement in lung function, as measured by the volume of air exhaled by patients in one second.

    Common adverse effects include headache, injection site reactions, back pain, and weakness (fatigue).

    Hypersensitivity reactions can occur within hours or days of being treated with mepolizumab, including swelling of the face, mouth, and tongue; fainting, dizziness, or lightheadedness; hives; breathing problems; and rash. Herpes zoster infections have occurred in patients receiving mepolizumab.

  • June 3, 2015

    FDA approved sirolimus to treat lymphangioleiomyomatosis (LAM), a rare, progressive lung disease that primarily affects women of childbearing age. This is the first drug approved to treat the disease.

    LAM is characterized by an abnormal growth of smooth muscle cells that invade lung tissues (including the airways) and blood/lymph vessels, causing destruction of the lung. LAM is a very rare disease. According to the National Library of Medicine, only between two and five women per million women worldwide are known to have the disease.

    Available as both a tablet and an oral solution, sirolimus was originally approved in 1999 as an immunosuppressive agent to help prevent organ rejection in patients 13 years and older receiving kidney transplants. Because sirolimus’s sponsor demonstrated that the drug may offer a substantial improvement over available therapies, it received breakthrough therapy designation. It also received a priority review and orphan product designation.

    Development of this drug was also supported in part by the FDA Orphan Products Grants Program, which provides grants for clinical studies on safety and/or effectiveness of products for use in rare diseases or conditions.

    Safety and efficacy of sirolimus for the treatment of LAM were studied in a clinical trial that compared sirolimus with placebo in 89 patients for a 12-month treatment period, followed by a 12-month observation period. The primary endpoint was the difference between the groups in forced expiratory volume in one second (FEV1). The difference in the average decrease in FEV1 during the 12-month treatment period was approximately 153 mL. After discontinuation of sirolimus, the decline in lung function resumed at a rate similar to the placebo group.

    The most commonly reported adverse effects were mouth and lip ulcers, diarrhea, abdominal pain, nausea, sore throat, acne, chest pain, leg swelling, upper respiratory tract infection, headache, dizziness, muscle pain, and elevated cholesterol. 

    Serious adverse effects including hypersensitivity and edema have been observed in renal transplant patients.